PASAT for Fibromyalgia

Overseen By Melyssa Godfrey, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Chronic disease, Vision loss, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Fibromyalgia (FM) is a chronic musculoskeletal pain disorder with unknown causes. Our previous studies showed abnormal sensations of second pain (wind-up), indicating central hypersensitivity as an important mechanism of FM. Triggering events have been implicated as the cause of central hypersensitivity.

Do I need to stop my current medications for the trial?

Yes, if you are a fibromyalgia patient, you must stop taking your fibromyalgia-related medications for at least one day before the visit.

How is the PASAT treatment different from other treatments for fibromyalgia?

The PASAT treatment is unique because it focuses on improving cognitive functions like working memory and attention, which are often impaired in fibromyalgia patients. Unlike typical pain management treatments, PASAT targets the brain's ability to process information and manage tasks, potentially addressing cognitive deficits associated with the condition. ^{1 2 3 4 5}

Who Is on the Research Team?

Roland Staud, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for individuals diagnosed with Fibromyalgia (FM) who have experienced pain for more than 3 months and meet specific diagnostic criteria. Healthy people without chronic pain can also join as controls. Participants should not have chronic diseases or significant vision loss, and FM patients must pause their medications for at least a day before the visit.

Inclusion Criteria

I am healthy, without chronic pain, and match the age and sex criteria.

I have been diagnosed with fibromyalgia and have had pain for more than 3 months.

Exclusion Criteria

I am willing to stop my fibromyalgia medication for at least one day before my visit.

I have a long-term illness like cancer or diabetes.

Significant vision loss not corrected by eye wear

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Baseline evaluation of light and pain sensitivity using QST examinations and VEP

1-2 weeks

1 visit (in-person)

Experimental Task

Participants undergo the PASAT task to assess sensory testing responses

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after experimental tasks

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Paced Auditory Serial Addition task (PASAT)

Trial Overview The study is testing how people with FM respond to a Paced Auditory Serial Addition Task (PASAT), which may help understand central hypersensitivity—a key mechanism in FM that relates to abnormal pain perception.

How Is the Trial Designed?

Group I: Effects of PASAT on Sensory Testing Experimental Treatment 1 Intervention

After baseline evaluation of light and pain sensitivity FM subjects and controls will undergo the PASAT task. This task consists of responding to a rapid presentation of numbers by ear phones. Subjects are asked to add each 2 consecutive numbers and provide a response each time the sum is equal to 13. This test will last several minutes and delivered at increasing speed.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

Individuals with fibromyalgia show significant impairments in cognitive functions related to controlled processes, particularly in tasks involving working memory and executive function.

The study found that both temporal orienting (faster reaction times for attended targets) and response inhibition were notably worse in fibromyalgia patients compared to a control group, suggesting dysfunction in the frontal networks responsible for attentional control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal preparation and inhibitory deficit in fibromyalgia syndrome. Correa, A., Miró, E., Martínez, MP., et al.[2019]

Patients with fibromyalgia (FM) showed a significant increase in pain sensitivity during an experiment, indicating a long-lasting sensitization to pain despite no initial difference in pressure pain thresholds compared to healthy controls.

Electrophysiological data revealed that FM patients had altered cognitive processing of pain-related information, as evidenced by reduced P200 amplitudes and a lack of enhanced responses to unpleasant words, suggesting a different way of processing emotional pain stimuli.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Altered processing of pain-related information in patients with fibromyalgia. Montoya, P., Pauli, P., Batra, A., et al.[2006]

In a study involving 50 fibromyalgia patients and 60 healthy controls, the expected increased auditory processing in fibromyalgia patients was not observed; instead, they showed reduced auditory event-related potentials (AEPs) to loud sounds.

Medication with central effects was found to significantly reduce AEPs in fibromyalgia patients, suggesting that while sensory amplification may not be evident, it could still play a role in the condition's underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of intensity, attention and medication on auditory-evoked potentials in patients with fibromyalgia. Samartin-Veiga, N., González-Villar, AJ., Triñanes, Y., et al.[2021]

In a study of 209 fibromyalgia patients and 72 control patients, those with fibromyalgia showed a significantly higher rate of deficits in lexical access speed (48.3%) compared to controls (25.0%), indicating a potential cognitive challenge associated with the condition.

The average delay in lexical access speed was 171 milliseconds for fibromyalgia patients, which correlated with deficiencies in cognitive performance across multiple measures, supporting the idea that lexical access speed is crucial for overall cognitive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive dysfunction in fibromyalgia: slow access to the mental lexicon. Leavitt, F., Katz, RS.[2015]

In a study of 36 women with fibromyalgia, cognitive performance was assessed using the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA), revealing that the MoCA may be a more sensitive tool for detecting cognitive impairment in these patients.

The results indicated a significant relationship between cognitive performance on these tests and physical fitness, as measured by the TUG dual-task test, suggesting that cognitive assessments can aid in diagnosing cognitive impairment in fibromyalgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MoCA vs. MMSE of Fibromyalgia Patients: The Possible Role of Dual-Task Tests in Detecting Cognitive Impairment. Murillo-Garcia, A., Leon-Llamas, JL., Villafaina, S., et al.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Temporal preparation and inhibitory deficit in fibromyalgia syndrome. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Altered processing of pain-related information in patients with fibromyalgia. [2006]

3. England pubmed.ncbi.nlm.nih.gov

Effects of intensity, attention and medication on auditory-evoked potentials in patients with fibromyalgia. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Cognitive dysfunction in fibromyalgia: slow access to the mental lexicon. [2015]

5. Switzerland pubmed.ncbi.nlm.nih.gov

MoCA vs. MMSE of Fibromyalgia Patients: The Possible Role of Dual-Task Tests in Detecting Cognitive Impairment. [2021]